The invention relates to a composition for enteral nutrition comprising fibres.
More precisely, the object of the invention is a composition for enteral nutrition comprising branched maltodextrins.
Artificial nutrition makes it possible, in adults as in children, to compensate for a defective intestine, to put an inflammatory intestine to rest, to correct severe undernourishment in a patient unable or unwilling to eat, either because of a serious condition, or because of a cumbersome treatment. Its duration can extend from a few days to four weeks to several months or years. Depending on the cases, the artificial nutrition will be performed by the digestive route (enteral nutrition) or by the venous route (parenteral nutrition). Always introduced in a hospital setting, in medicine, surgery and intensive care, artificial nutrition can now be continued at home in cases requiring a very prolonged treatment. The basic principle of enteral or parenteral artificial nutrition is the supply of all the nutrients necessary for life: sugars, fats, proteins, minerals, trace elements, vitamins, which the subject can no longer take in by the usual oral route.
Enteral nutrition is the most simple and the most physiological route for nutritive assistance. The site of delivery is in general intragastric, with the aid of a tube introduced by the nasal route. An effective and well-tolerated enteral nutrition involves two basic technical principles: the slowness (1 to 3 ml/min) and the continuous nature (from 12 h to 24 h per day) of the food instillation.
In the case of extensive intestinal lesions compromising the functions of absorption, the foods used are predigested (amino acids, monosaccharides).
When the small intestine is still functional, a semi-basic diet composed of less degraded, or even nondegraded, nutrients is used. Minerals, trace elements and vitamins, are added systematically and daily. The nutrients are prepared, mixed and stored under conditions of strict cleanliness, or even asepsis in case of industrial preparation.
Hospitalized patients and in particular patients on antibiotics or suffering from intestinal disorders, resulting either in constipation, or in diarrhoeas and receiving nutritional assistance by the enteral route need a supply of appropriate fibre.
The fibres are recognized for their beneficial effects on human health and should form an integral part of the daily food supplies. Fibres are generally classified into two categories: soluble fibres and insoluble fibres. Soluble fibres, such as pectin, inulin, resistant starches are fermented by the intestinal bacterial flora. This fermentation releases short-chain fatty acids in the colon, which have the effect of reducing the pH thereof and consequently of limiting the development of pathogenic bacteria.
Insoluble fibres, such as cellulose, maize or soya bean fibres have an essentially mechanical role in the gastrointestinal tract. They are only very slightly fermented by the intestinal flora and contribute to reducing the duration of the intestinal transit.
A fibre-enriched composition for enteral nutrition should ideally:
be similar to the fibres conventionally consumed;
generate a production of beneficial volatile fatty acids;
not cause flatulence in the patient;
improve intestinal motility;
not have residues;
be soluble;
have adequate viscosity so as to facilitate its instillation;
be stable during storage and during sterilization;
be gradually assimilated;
promote mineral absorption.
Several compositions for enteral nutrition containing fibres have been proposed. Pectin fibres have been proposed, but have disadvantages such as an excessively high viscosity, and a lack of improvement in mineral absorption.
Patent EP-B1 0,756,828 describes fibre-enriched compositions, containing a mixture of soluble fibres, insoluble fibres and resistant starch. These compositions contain a high proportion of soluble fibres and have a high viscosity which is not suited to instillation by a tube. These compositions also have problems of stability.
The document EP-A1 1,010,374 describes a mixture of fibres for enteral nutrition comprising soluble and insoluble pea fibres, inulin and fructooligosaccharides. These compositions are also too viscous especially because of the presence of pea fibres and inulin which are scarcely soluble; the fructooligosaccharides are not stable during sterilization. This instability results in gradual hydrolysis, which generates a release of glucose and fructose and a colour which are undesirable. These mixtures of fibres only partially promote mineral absorption, and are not gradually assimilated. Moreover, the pea fibres and inulin generate problems of flatulence in the patient. As for the fructooligosaccharides, these molecules remain poorly tolerated by the body, which is expressed by the onset of diarrhoea.
The aim of the present invention is therefore to remedy the disadvantages of the prior art. The applicant has indeed found that the incorporation of the said branched maltodextrins into a composition for enteral nutrition advantageously makes it possible to reconcile all these objectives which have up until now been reputed irreconcilable by devising and producing, at a cost of numerous research studies, a novel fibre-enriched composition for enteral nutrition which meets all the abovementioned criteria, namely the viscosity, the solubility, a satisfactory stability during storage and during sterilization manifested by the absence of retrogradation, a gradual assimilation, an absence of generation of flatulence, and a considerable improvement in mineral, and in particular calcium and magnesium, absorption.
The subject of the invention is therefore a fibre-enriched composition for enteral nutrition, characterized in that it comprises branched malto-dextrins having between 15 and 35% of 1xe2x86x926 glucoside linkages, a reducing sugar content of less than 20%, a polymolecularity index (ratio of weight-average molecular mass over number-average molecular mass) of less than 5, and a number-average molecular mass Mn at most equal to 4500 g/mol.
The expression branched maltodextrins is understood to mean, for the purposes of the present invention, the maltodextrins described in patent application EP 1,006,128 of which the assignee is proprietor. These branched maltodextrins have an indigestibility character which has the consequence of reducing their calorific value, by preventing their assimilation in the small intestine. They therefore represent a source of indigestible fibres beneficial to the metabolism and the intestinal balance. As a guide, their insoluble fibre level is generally greater than 506 on a dry matter basis. Their high content of 1xe2x86x926 glucoside linkages confers quite particular prebiotic properties on them: it has indeed appeared that the bacteria of the cxc3xa6cum and of the colon of humans and of animals, such as butyrogenic, lactic or propionic bacteria, metabolize highly branched compounds. Moreover, these branched maltodextrins promote the development of the bifidogenic bacteria to the detriment of the undesirable bacteria. This results in properties which are quite beneficial to the health of the consumer. Finally, the branched character of the said maltodextrins considerably and advantageously reduces their tendency to undergo retrogradation, which makes it possible to envisage their use in applications where the absence of retrogradation is necessary, in particular during prolonged storage in aqueous solution.
All the branched maltodextrin compositions described in patent application EP 1,006,128 and its US counterpart (U.S. Pat. No. 09/455,009; Assignee Roquette Frxc3xa8res) are appropriate for the preparation of compositions for enteral nutrition according to the invention. The entire content of U.S. Ser. No. 09/455,009 is herein incorporated by reference.
According to a preferred variant, they have a reducing sugar content of between 2 and 5% and a number-average molecular mass of between 2000 and 3000 g/mol.
According to another advantageous variant, all or some of these branched maltodextrins are hydrogenated, they are thus advantageously even more stable during sterilization.
A fibre-enriched composition for enteral nutrition in accordance with the invention comprises 0.5 to 20%, preferably 1 to 10%, and still more preferably 1 to 5% by dry weight of branched maltodextrins so as to constitute a fibre supply and a sufficient energy supply. The branched maltodextrins have an insoluble fibre level greater than 50% on a dry basis, determined according to the AOAC No. 985-29 method (1986). Below 0.5% by weight of maltodextrins in the composition for enteral nutrition in accordance with the invention, the fibre supply is insufficient to have a detectable effect.
The apparent improvement in the absorption of calcium and magnesium is shown in particular in animals and leads to remarkable results as will be otherwise exemplified, making it possible to envisage the preparation of compositions for enteral nutrition which improve the calcium and magnesium status of the patient. This is surprising and unexpected for fibre-rich compounds whose negative influence on the absorption of mineral elements is known.
It was moreover found that the branched maltodextrins according to the invention did not generate osmotic diarrhoeas, even at high doses. The phenomenon of osmotic diarrhoea is observed during absorption of low-molecular weight fermentable carbohydrates, such as for example lactulose or fructooligosaccharides. This phenomenon results in an increase in the water content of stools in reaction to an increase in the osmolarity of the faecal content, it being possible for this increase in water content to extend as far as the appearance of diarrhoeas. Surprisingly, and unexpectedly, the branched maltodextrins in accordance with the invention do not generate this phenomenon although they are fermentable.
The composition for enteral nutrition in accordance with the invention also comprises a source of proteins, lipids and carbohydrates. Preferably, the proteins represent about 10 to 20% of the energy supply of the composition. They are, for example, supplied by animal proteins such as milk proteins, or soya bean proteins or alternatively proteins of cereal origin. They may be provided in native or hydrolysed form so as to provide a source of free amino acids.
The lipids preferably constitute 30 to 50% of the energy supply of the composition, in the form of monounsaturated, polyunsaturated and saturated fatty acids. Any oil is indeed suitable, such as for example olive, maize, sunflower, wheat and oils.
The carbohydrates, other than the said branched maltodextrins, preferably represent 35 to 55% of the energy supply. They may be provided by standard or modified starches, high amylose starches, modified or otherwise, standard maltodextrins, simple sugars. The branched maltodextrins according to the invention may of course constitute both an energy supply and a fibre supply.
The composition for enteral nutrition according to the invention may also be supplemented with a complete vitamin and mineral supply. Flavourings, sweeteners and other additives may also be added.
Although not a preferred variant of the invention, the said branched maltodextrins may be completely or partially replaced with indigestible dextrins such as in particular FIBERSOL(copyright) marketed by the company MATSUTANI. However, as the latter are low in insoluble fibres, they are advantageously mixed with the said branched maltodextrins.
Accordingly, the composition for enteral nutrition in accordance with the invention may comprise branched maltodextrins mixed with indigestible dextrins.
The said composition may be provided in a ready-to-use form, that is to say in a form which can be instilled by means of a gastric tube, or alternatively in the form of a drink such as a fruit juice, a soup or a milk shake, or alternatively in the form of dessert creams or yoghurts directly consumed by the patient or which can be administered by a tube.
The said composition may also be provided in the form of a powder to be reconstituted in a liquid.
The branched maltodextrins according to the invention exhibit a stability in acidic medium and a stability to heat treatments which are quite advantageous when it is desired to prepare compositions for enteral nutrition at slightly acidic to acidic pH, such as, for example drinks, soups or fruit juices. This stability has not been observed for fructooligosaccharides. Furthermore, when compositions are prepared which are intended to be sterilized, it is often preferred that these compositions are slightly acidic so as to avoid the caramelization of the sugars during the heat treatment. The stability of the branched maltodextrins in acidic medium and/or to heat is therefore quite advantageous and appropriate.
The composition for enteral nutrition, whether it is solid or liquid, will be preferably sterilized by any technique known to persons skilled in the art and packaged, if necessary, in boxes, pouches or sterile bottles.
The preparation per se of the liquid or solid composition for enteral nutrition may be carried out by any conventional technique, consisting, for example, in simply mixing the various powdered ingredients, or in spray-drying a solution comprising all the said ingredients. When a liquid form is involved, the said composition should be easily administerable by means of a tube, or by mere gravity, or by pumping. It should then have a reduced viscosity, for example of less than 40 mPa.s at room temperature.
The said composition for enteral nutrition may be used in animals.